The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.

Device Description

The Veloxion System consists of the following components:

Veloxion Controller (with Integrated Fluid Control)
- Footswitch
Veloxion Resectoscope
Veloxion Fluid Control Set
Veloxion Video Control Unit
Veloxion Roll Stand

The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:

Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
Tissue Catch: For collection of gross resected tissue pieces for pathology.
Waste Management Bags: To provide bags for final collection of outflow.

The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit. The components of Veloxion System perform the following functions:

The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.

AI/ML Overview

This document, a 510(k) Premarket Notification for the Veloxion System, details the device's characteristics and its equivalence to previously cleared predicate devices, allowing it to be marketed. However, it explicitly states, "No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates."

This crucial statement means the provided text does not contain the acceptance criteria or a study that proves the device meets the acceptance criteria directly within this submission. It relies on previous clearances (K190099 and K162979) and their associated testing.

Therefore, many of the requested details about acceptance criteria, specific performance data, sample sizes, ground truth establishment, and expert involvement are not present in this document.

Despite this, I will extract what information is available and clearly indicate where details are missing based on the document's content.

Based on the provided document, specific details regarding the acceptance criteria and a standalone study proving the device meets these criteria are NOT presented. The submission relies on demonstrating substantial equivalence to predicate devices, referencing prior clearances (K190099 and K162979) for performance data.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

Not provided in this document. The document states "No new performance testing was required" for this submission, indicating that performance data relies on previous clearances of the Veloxion System (K190099, K162979) and comparative testing against other predicates. This document does not present a table of acceptance criteria or new reported performance data.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in this document. No new test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided in this document. As no new test set or ground truth establishment is described for this submission, this information is not available. This would typically be relevant for studies involving diagnostic or image-based AI, which this device is not.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided in this document. No test set or human adjudication process is described for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided in this document. This device is a surgical system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant in this context, and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided in this document. The Veloxion System is a physical medical device (resectoscope system), not a standalone algorithm or AI. Its performance is tied to its mechanical and electronic functions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided in this document. For a physical device like the Veloxion System, "ground truth" would typically relate to engineering specifications, performance parameters (e.g., fluid flow rates, power output, pressure control accuracy), and safety standards, rather than clinical diagnostic "ground truth" established by experts or pathology. This document does not detail the specific performance testing or the "ground truth" metrics used in prior clearances.

8. The sample size for the training set

Not applicable/Not provided in this document. The Veloxion System is a hardware device with integrated software for control and monitoring. While software verification testing is mentioned (point below), there's no indication of a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable/Not provided in this document. As above, no "training set" in the machine learning sense is described. The document mentions "Software Verification Testing was performed using the same protocol reviewed as part of K 190099 for all steps affected by the change and documentation updated per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This indicates adherence to software validation best practices, but not a machine learning training paradigm.

Summary of what the document does provide:

Device Name: Veloxion System
Predicate Devices: K190099, K162979 (both Corinth MedTech, Inc. Veloxion System), K062720, K042523 (Richard Wolf Medical Instruments Corporation systems).
Indications for Use: The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.
Technological Characteristics Comparison: A detailed table comparing the subject device's energy type, RF functions, cavity pressure monitoring, irrigation fluid, outer sheath dimensions, electrode extension, and electrode movement to its predicates. Minor differences are noted.
Performance Data Statement: "No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates."
Software Verification: Mentions software verification testing was performed using the same protocol as K190099, updated per FDA guidance for software in medical devices.

In essence, this 510(k) submission is a "Special 510(k)" which often means a modification to an already cleared device, and thus relies on demonstration of substantial equivalence rather than entirely new performance studies. The detailed studies proving acceptance criteria were conducted for the original clearances (K190099 and K162979).

Summary

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June 13, 2019

Corinth MedTech, Inc. Sandeep Saboo Vice President. Ouality Assurance & Regulatory Affairs 1601 S. De Anza Blvd., Suite 200 Cupertino, CA 95014

K191341 Re: Trade/Device Name: Veloxion System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FJL, KQT, GEI Dated: May 15, 2019 Received: May 20, 2019

Dear Sandeep Saboo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or (301) 796-7100).

Sincerely,

for Glenn B. Bell. Ph.D. Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191341

Device Name Veloxion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K191341: 510(k) Summary I.

Submitter Information

Submitter name:	Corinth MedTech, Inc.1601 S. De Anza Blvd, Suite 200Cupertino, CA 95014
Contact person:	Sandeep SabooVice President, Regulatory Affairs and Quality AssurancePhone: (408) 996-2517Fax: (408) 996-0621
Date Prepared:	14 May 2019

II. Product Classification

Device Name:	Veloxion System
Common Name:	Resectoscope	Subject Device
Regulation:	21 CFR 876.1500
Regulation Name:	Endoscope and accessories
Class:	II
Product Code:	FJL
Additional Product Codes:	KQT, GEI

III. Predicate Devices

The predicate device is the system comprised of the following legally marketed devices as used in combination to which substantial equivalence is claimed:

Predicate	Manufacturer	Predicate Device Names	510(k)#	Clearance Date
Primary PredicatePredicate #1	Corinth MedTech, Inc.	Veloxion System	K190099	March 15, 2019
Predicate #2(predicate system)	Richard Wolf MedicalInstrumentsCorporation	S-Line Bipolar Resectoscope& ERBE ESU	K062720	March 22, 2007
Predicate #3(predicate system)	Richard Wolf MedicalInstrumentsCorporation	Resection Master & ERBEESU	K042523	March 18, 2005
Predicate #4(predicate system)	Corinth MedTech, Inc.	Veloxion System	K162979	March 24, 2017

Predicate devices have not been the subject of a design related recall.

IV. Device Description

The Veloxion System consists of the following components:

· Veloxion Controller (with Integrated Fluid Control)
- o Footswitch
· Veloxion Resectoscope
· Veloxion Fluid Control Set
Veloxion Video Control Unit
Veloxion Roll Stand

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K191341

· Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
· Tissue Catch: For collection of gross resected tissue pieces for pathology.
· Waste Management Bags: To provide bags for final collection of outflow.

· The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
· The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
· The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.

V. Indications for Use

There is no difference in the indications for use for the modified Veloxion System (subject device) when compared to the predicate devices.

Comparison of Indications for Use
Device	Indications For Use
ModifiedVeloxion System(Subject Device)	The Veloxion System is intended for use by trained urologists for endoscopicallycontrolled tissue chip resection and coagulation, and removal of prostate adenomas andbladder tumors (TURBT) via suction channel under continuous flow conditions followingresection using a bipolar resectoscope.
Veloxion SystemK190099(Primary Predicate)Predicate #1	The Veloxion System is intended for use by trained urologists for endoscopicallycontrolled tissue chip resection and coagulation, and removal of prostate adenomas viasuction channel under continuous flow conditions following resection using a bipolarresecting device.

Comparison of Indications for Use

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Veloxion System

SPECIAL 510(k) Premarket Notification

Device	Indications For Use
Predicate #2K062720(Predicate system)	S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissueusing 0.9% NaCl solution (saline) as the irrigation medium.For Urology:Urological surgical procedures involving the ablation or removal of soft tissue and whereassociated hemostasis is required.Transurethral resection of the prostate (TURP) and bladder neck.Transurethral resection of the bladder tumors (TURBT)Transurethral incision of the prostate.Coagulation of bleeding in the lower urinary tract.For Gynecology:Tissue cutting, removal, and desiccation as required or encountered in gynecologichysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps,adhesions, septa, and benign conditions requiring endometrial ablation.Excision of intrauterine myomas.Excision of intrauterine polyps.Lysis of intrauterine septa.Endometrial ablation.
Predicate #3K042523(Predicate system)	The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopicallycontrolled tissue chip resection and removal of intrauterine polyps, intrauterine myomas orprostate adenomas via suction channel under continuous flow conditions followingresection using a high-frequency electrode with a Resectoscope.
Predicate #4K162979(Predicate system)	The Veloxion System is intended for endoscopically controlled tissue chip resection andcoagulation and removal of prostate adenomas via suction channel under continuous flowconditions following resection using a bipolar resecting device.

VI. Comparison of Technological Characteristics with the Predicate Device

The subject Veloxion System and the previously cleared predicate devices have the same or similar technological characteristics (see Table 1) in terms of basic operating principle and basic design features.

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Veloxion System SPECIAL 510(k) Premarket Notification

						Table 1: Comparison of subject Veloxion System and predicate:
--	--	--	--	--	--	---------------------------------------------------------------

Technological Characteristics	VELOXION SYSTEM(Subject)	VELOXION SYSTEM(Predicate System)K190099 & K162979	Richard Wolf S-LineResectoscope System(Predicate System)K062720	Richard Wolf Resection MasterSystem(Predicate System)K042523
Energy Type:	Radiofrequency, bipolar	Radiofrequency, bipolar	Radiofrequency, bipolar	Radiofrequency, bipolar
RF Functions:	Cut, Coagulation	Cut, Coagulation	Cut, Coagulation	Cut, Coagulation
Able to Set & Monitor CavityPressure?	YES	YES	YES	YES
Irrigation fluid:	Saline	Saline	Saline	Saline
Outer Sheath Working Length:	220mm	K190099: 220mmK162979: 193mm	186mm	186mm
Outer Sheath OD:	25Fr (8.3mm)	K190099: 25Fr (8.3mm)K162979: 26Fr (8.6mm)	27Fr (9.0mm)	27Fr (9.0mm)
Inner Sheath OD:	19.5 Fr (6.5mm)	K190099: 19.5 Fr (6.5mm)K162979: N/A	21 Fr (7mm)	N/A
Max Electrode Extension outsideSheath:	20mm	K190099: 20mmK162979: 23mm	21mm	21mm
Electrode Wire OD:	0.019"	K190099: 0.019"K162979: 0.015"	0.010inch to 0.015inch	0.010inch to 0.015inch
Electrode Movement:	Linear Oscillation at 3000cpm	K190099:Linear Oscillation at 3000cpmK162979:Linear Oscillation at 1000cpm	Stationary on the distal end	Stationary on the distal end

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Corinth MedTech, Inc.

There are minor differences in the technological characteristics between the subject Veloxion System and the predicates. The minor differences do not raise new or different questions of safety and effectiveness for the intended use of the device as it pertains to the expansion of the indications for use.

VII. Performance Data

No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates.

. Software Verification Testing was performed using the same protocol reviewed as part of K 190099 for all steps affected by the change and documentation updated per FDA 's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

VIII. Conclusions

The subject Veloxion System is considered substantially equivalent and as safe and effective as the identified predicate devices (predicate systems).

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.